510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,069 of the 176,466 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,669
176,466 records, page 2740 of 3530
510(k) clearances, page 2740 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K881522Dextrose AgarNeogen Culture MediaJSGClass I
K881512Wescor Gram Stain Pack for Model 7300 AerosprayELITechGroup IncJTSClass I
K881486Dnase Test AgarNeogen Culture MediaJSHClass I
K881477Histogrip & Histogrip Gold Concentrate/predilutedStat PathKELClass I
K881467Microscope Stage HeaterCryodyne Technologies, Inc.KEJClass I
K881466Cell-Culture ShakerCryodyne Technologies, Inc.KJBClass I
K881354RajahJ.F. Jelenko & Co., Inc.EJTClass II
K881124Allegro(tm) Luteinizing Hormone ImmunoassayNichols Institute DiagnosticsCEPClass I
K881054Calcium, Catalogue Number 122-20Diagnostic Chemicals, Ltd. (USA)CICClass II
K880934Modified Amerlex-M Progesterone Radioimmuno. KitAmersham Corp.JLSClass I
K880809Illumina Model 55 CO2 Laser for General/plastic SuCooper Lasersonics, Inc.GEXClass II
K880808Illumina Model 40 CO2 Laser for General/plastic SuCooper Lasersonics, Inc.GEXClass II
K880807Illumina Model 25 CO2 Laser for General/plastic SuCooper Lasersonics, Inc.GEXClass II
K880798Acid Phosphatase ReagentTrace America, Inc.CKBClass II
K880796Alkaline Phosphatase Reagent, Dea BuffTrace America, Inc.CJEClass II
K880795Resubmitted Alkaline Phosphatase Reagent Amp Buff.Trace America, Inc.CJEClass II
K880794Resubmitted Bicarbonate (CO2) Reagent Single VialTrace America, Inc.KHSClass II
K880792Plastic PrimerReliance Orthodontic Products, Inc.DYHClass II
K880790Porcelain PrimerReliance Orthodontic Products, Inc.DYHClass II
K880765G-Cera Porcelain BondG-C Intl. Corp.EBFClass II
K880758Sucrosep Specific Immunoradiometric AssayBoots-Celltech Diagnostics, Inc.CEPClass I
K880622Labco Limited Exetainer(r)Labco, Ltd.JKAClass II
K880621CapcaddyCapcad, Inc.EJIClass II
K880619Emit T-Uptake Assay Thyroid Hormone Binding RatioSyva Co.KHQClass II
K880585Dexpad, Blood Glucose StripMach Diag. C/O Wichita State UniversityCGAClass II
K880492Intercept t.e.n.s. DeviceMedical Design & Manufacturing Corp.GZJClass II
K880429Illumina 55 CO2 Laser SystemCooper Lasersonics, Inc.EWGClass II
K880428Illumina 25 CO2 Laser SystemCooper Lasersonics, Inc.EWGClass II
K880427Illumina 40 CO2 Laser SystemCooper Lasersonics, Inc.EWGClass II
K880277Uric Acid Reagent SetTech-Neal Scientific, Inc.KNKClass I
K880194Kensey CatheterTheratek, Inc.LITClass II
K880087Abbott Imx T3Abbott MedicalCDPClass II
K875339Jetpolisher Airpolishing PowderYoung Dental Manufacturing Co 1, LLC.EJRClass I
K875211Glucose (Trinder) Cat. # 220-32Diagnostic Chemicals, Ltd. (USA)CGAClass II
K875208Chloride Cat. # 152-17Diagnostic Chemicals, Ltd. (USA)CHJClass II
K875207Albumin Cat. # 201-03Diagnostic Chemicals, Ltd. (USA)CIXClass II
K874683The Esi-2000 Ultrasound UnitElscint, Inc.IYOClass II
K874548Sim 4000COte-Biomedica Elettronica S.P.AIYOClass II
K881250Ace Pneumatic Oscillating SawBuckman Co., Inc.HSZClass I
K881114Empi Model 989, TENSEmpiGZJClass II
K875240Trans/v Needle GuideCIVCO Medical Instruments Co., Inc.IYOClass II
K875236Trans/p Needle GuideCIVCO Medical Instruments Co., Inc.IYOClass II
K875128Trans/r Needle GuideCIVCO Medical Instruments Co., Inc.IYOClass II
K874106Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc.LFDUnclassified
K881479Operation Room TowelRahn LaboratoriesKKXClass II
K881408Yesng Reusable Electrosurgical HandleFerguson MedicalGEIClass II
K881407Yesng Resuable Bipolar ForcepsFerguson MedicalGEIClass II
K881406Yesng Reusable Electrosurgical ElectrodeFerguson MedicalGEIClass II
K881230Flex TubeIntertech Resources, Inc.BZAClass I
K881178CuffcheckDhd Medical Products Div. Diemolding Corp.BSKClass II